FDA Registration
Active
🇨🇳 China
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Reg #: 3016610313
·
FEI: 3016610313
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- HANGZHOU LAIHE BIOTECH CO.,LTD.
- Registration Number
- 3016610313
- FEI Number
- 3016610313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240287
Owner / Operator
- Firm Name
- Hangzhou Laihe Biotech Co.,Ltd.
- Operator Number
- 10065287
- Address
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310051
- Country
- CN
- Correspondent
- Yun Ouyang
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2025-03-31 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2025-03-31 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2025-03-31 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2025-03-31 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2025-03-31 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2025-03-31 |
Proprietary Names
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Establishment Types
Manufacture Medical Device